Dry Eye Symptom Mitigation by Oral Intake of Probiotics

  • STATUS
    Recruiting
  • participants needed
    88
  • sponsor
    Chung Shan Medical University
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Updated on 16 June 2023
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Summary

This study investigates whether the oral intake of a probiotics capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 1 probiotics capsule per day for 35 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, tear osmolarity and serum biochemical test. After the 35 days are completed, the participants will be assessed again for the same parameters.

Description

This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to control group or treatment group, and asked to orally intake 1 capsule of either placebo or probiotics per day. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear osmolarity, ocular surface impression cytology, ocular surface disease index (OSDI) and serum biochemical tests for quantification of hyaluronic acid, sialic acid, glutathione contents.The assessments are conducted at day1 for baseline and after the 35-day oral intake. The parameters are used to compare and evaluate whether the probiotics can relieve dry eye symptoms.

Details
Condition Dry Eye
Age 20years - 65years
Treatment Placebo, Probiotics
Clinical Study IdentifierNCT05906381
SponsorChung Shan Medical University
Last Modified on16 June 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

aged between 20 and 65 years
with Schirmer's test results less than 10 mm or Ocular Surface Disease Index more than 25

Exclusion Criteria

evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy
diabetes
hypertension
or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
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